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The goal of this observational study is to learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patient with enlarged prostate and severe benign prostatic hyperplasia. The main question it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two-step Radical Prostatectomy | Two-step Radical Prostatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two-step Radical Prostatectomy | Procedure | The first step is enucleation of the hyperplastic adenoma, and the second step is anterograde RP to residual gland |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Recurrence-free Survival | Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical recurrence is measured by PSA levels. Biochemical recurrence was defined as a measurable serum PSA concentration 0.2 ng/ml or greater. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical time | Defined as the time duration from the incision at the opening to the end of closing the incision | Intraoperative |
| Estimated blood loss | Defined as all the blood loss counting during the surgery |
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Inclusion Criteria:
Exclusion Criteria:
Male with prostate cancer
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Low- to intermediate-risk localized prostate patient with enlarged prostate and severe benign prostatic hyperplasia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yonghong Li, M.D. | Contact | 020-87343656 | liyongh@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Intraoperative |
| Hospital stay | Defined as the time duration between the first day after surgery to the day of discharge | From date of surgery until the date of discharge, an average of 7 days |
| Continence | Evaluated with the use of pad per day. Using no more than 1 pad per day is defined as complete continence | 2 weeks, 1 months, 3 months, 6 months, 12 months after surgery |
| Lower urinary tract symptoms | Evaluated with International Prostatic Symptom Score (IPSS). 1-7: Mild 8-19:Moderate 20-35: Severe | 1 months, 3 months, 6 months, 12 months after surgery |
| Erectile function | Evaluated with International Index of Erectile Function-5 (IIEF-5).The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction | 6 months, 12 months and 24 months after surgery |
| Positive surgical margin rate | Defined as the proportion of patients with positive surgical margin of the whole prostate and the margin between the hyperplastic adenoma and the residual gland evaluated by pathologists. The location of positive margin will be documented. | Through study completion, an average of 5 year |
| Complication | All the complications which was evaluated relevant to the surgery will be documented and graded by Clavien-Dindo grade system. | Through study completion, an average of 5 year |
| Overall survival | Number of participants who are alive after a specified duration of time | From date of randomization until the date of date of death from any cause, assessed up to 60 months |
| Cancer-specific survival | Number of participants who are not dead due to prostate cancer after a specified duration of time | From date of randomization until the date of date of death from cancer, assessed up to 60 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |